Healthy Skepticism Library item: 9524

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Brown EG.
Patient information leaflets from pharmaceutical companies: survey of leaflets submitted to the Department of Health
Pharmaceutical Medicine 1989; 4:(2):123-129

Abstract:

The format, information content, and legality of 125 patient information leaflets submitted by 34 pharmaceutical companies to a United Kingdom regulatory agency are described. Of the total leaflets, 103 related to prescription only medicines, 17 to pharmacy medicines, and 4 were on the general sales list. Thirty-two leaflets were approved as submitted, 33 were refused for mainly legal or administrative reasons, 58 were refused mainly on medical or pharmaceutical grounds, 2 had not completed statutory assessment at the time of writing. There was great variability between leaflets from different companies in the way information was presented, although style and content tended to be consistent within a given company. Ninety of the 118 leaflets (76%) conformed approximately to the Association of the British Pharmaceutical Industry format. Although this format is advocated specifically for prescription medicines, 5 of the 18 pharmacy medicines were also presented in this way. Nearly all (97%) leaflets included some information on how the medicine should be taken. The majority (82%) of the leaflets provided advice about action to be taken if doses were missed or exceeded; it was often stated that, if a dose had been missed, it should be taken as soon as remembered. It was concluded that companies in the UK are attempting to improve their communications to patients; however, this appears to be a conservative trend based on the number of leaflets received for review.